Medical Devices; Third Party Review Under FDAMA

ICR 201611-0910-013

OMB: 0910-0375

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-12-21
ICR Details
0910-0375 201611-0910-013
Historical Active 201312-0910-005
HHS/FDA CDRH
Medical Devices; Third Party Review Under FDAMA
Extension without change of a currently approved collection   No
Regular
Approved without change 01/23/2017
Retrieve Notice of Action (NOA) 12/22/2016
  Inventory as of this Action Requested Previously Approved
01/31/2020 36 Months From Approved 01/31/2017
260 0 260
13,024 0 13,024
0 0 0

This ICR collects information from persons who wish to be accredited by the Agency to review certain premarket notifications. Participation in this third-party review program by accredited persons is entirely voluntary. A third party wishing to participate will submit a request for accreditation to FDA. Accredited third-party reviewers have the ability to review a manufacturer's premarket notification for selected medical devices. After reviewing a submission, the reviewer will forward a copy of the submission, along with the reviewer's documented review and recommendation to FDA. Third-party reviewers also maintain records of their reviews and a copy of the submission. The purpose of the program is: (1) to provide manufacturers of eligible devices with an alternative review process that could yield more rapid marketing clearance decisions and (2) enable FDA to target its scientific review resources at higher-risk devices while maintaining confidence in the review by third parties of low-to-moderate risk devices.

US Code: 21 USC 523 Name of Law: null
  
None

Not associated with rulemaking

  81 FR 44627 07/08/2016
81 FR 90857 12/15/2016
No

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 260 260 0 0 0 0
Annual Time Burden (Hours) 13,024 13,024 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$2,374
No
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
12/22/2016


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